Clinical Evaluation, Motor Performance and Quality of Life in Patients Affected by Soft Tissue Sarcomas, Undergoing Surgical Treatment: Observational Study

Recruiting

• Conditions: Sarcoma

• Registration Number: NCT06282237
• Lead Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico

Brief Summary

The main aim of the study is evaluate quality of life and motor performance of patients with soft tissue sarcomas undergoing surgical treatment and post-operative rehabilitation treatment.

Primary objectives:

* Identification of clinical characteristics and motor damage after surgery for soft tissue sarcomas;

* Impact of perioperative treatments and surgery on the quality of life of patients with soft tissue sarcomas;

* Impact of post-operative rehabilitation treatment on quality of life and recovery of motor activity The primary endpoint will be the improvement in the Toronto Extremity Salvage Score (TESS) between T1 (post-surgery) and T3 (at the end of rehabilitation treatment).

Secondary endpoints will be:

1. the evolution over the various timepoints of the selected rating scales (Toronto Extremity Salvage Score, Musculoskeletal Tumor Society Rating Scale, Numerical Rating Scale, Brief Pain Questionnaire, Douleur Neuropathique en 4 Questions, Leeds Assessment of Neuropathic Symptoms and Signs Scale, European Organization for Research and Treatment of Cancer, Quality-of-Life Questionnaire (QLQ)-C30, Short Form Health Survey 36);

• The change in walking performance before and after the rehabilitation treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2024-01-29
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-27
• Last Update Submitted: 2024-02-27
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Primary Completion: 2025-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Adult patients affected by primary localized soft tissue sarcoma, candidate to limb/trunk surgery with wide excision or retroperitoneal resection (including resection of the iliopsoas muscle with possible damage to the femoral nerve) with curative intent.

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Exclusion Criteria

• Patients with recurrent tumors;
• patients with metastatic disease;
• patients with palliative surgery;
• patients with amputations.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in the Toronto Extremity Salvage Score (TESS)	T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)	a change in the TESS greater than 7 points

Secondary Outcome Measures

Name	Time	Method
Pain evaluation	T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)	Leeds Assessment of Neuropathic Symptoms and Signs Scale
Motor performance evaluation	T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)	Musculoskeletal Tumor Society Rating Scale
Evaluation of Quality of Life	T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)	Short Form Health Survey 36

Trial Locations

Locations (1)

Fondazione Policlinico Campus Biomedico; 🇮🇹 Roma, Italy